NCT06455566

Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Leadless pacemakers (LP) are associated with a lower risk of revision compared with transvenous pacemakers. However, LPs implantation is associated with a 0.6% risk of complication at the femoral vein puncture site (e.g. arteriovenous fistula, haemorrhage, pseudoaneurysm, etc.). As a consequence, the need for prolonged in-hospital monitoring after LP implantation though the right femoral (RF)vein is a barrier to same-day discharge. Recently, right internal jugular (RIJ) vein access has emerged an alternative to right RF vein access for LP implantation (with a regulatory approval for MEDTRONIC Micra LP). The aims of this registry are the following : * evaluate the feasibility of RIJ access for LP implantation; * confirm the acute and chronic safety of RIJ access for LP implantation; * compare RIJ to RF (historical cohort) vein access regarding procedural characteristics and outcomes; * evaluate the feasibility of same-day discharge avec LP implantation through the RIJ vein.

Conditions

• Leadless Pacemaker
• Same-day Discharge

Interventions

Type	Name	Description
DEVICE	Leadless pacemaker implantation through right internal jugular vein	Leadless pacemaker implantation through right internal jugular vein

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-05-01
• Completion: 2027-05-01
• First posted: 2024-06-12
• Last updated: 2025-03-26

Locations

13 sites across 1 country: France